Catalog Number C-HSK-3043 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3 mm did not deploy correctly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint number: (b)(4).Autonumber: (b)(4).The hsk iii device was returned to the factory for evaluation.Signs of clinical use were and evidence of blood were observed.The delivery device and the loading device were returned.Both the delivery and loading devices was covered in blood.There was blood detected on the seal.The blue slide lock was observed to be disengaged and the white plunger was fully depressed on the delivery device.No failures were observed.The tension spring assembly remained in the delivery tube with the seal extended outside the tube.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.The seal was removed from the delivery device.The seal was observed to be completely in tact with no signs of crack/delamination.Based on the received condition of the device we were not able to measure the delivery tube dimensions.Based upon the received condition of the device, the reported failure ¿activation problem¿ is not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm did not deploy correctly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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